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Sanofi Phase II trial of Sanofi JAK2 inhibitor in MF met primary endpointSanofi announced new Phase II data showing that treatment with a novel, investigational, selective JAK2 inhibitor (SAR302503) reduced spleen size and improved constitutional symptoms in patients with intermediate-2 or high-risk primary or secondary myelofibrosis, MF, a hematologic malignancy with unmet medical needs. The data were presented during the 2012 Annual Meeting of the American Society of Hematology in Atlanta, Ga., December 8-11.

Sanofi reports positive opinion from CHMP for ToujeoSanofi announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has issued a positive opinion recommending the approval of Toujeo, a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus with low within-individual, within-day blood sugar variability. The European Commission is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the FDA and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units, and it has a maximum single injection dose of 80 IU.

Sanofi receives FDA approval of once-daily basal insulin ToujeoSanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.